Study to Assess Length of Remission With Intensive Chemotherapy in Rapidly Responding AML Patients. (AML)

April 4, 2019 updated by: Dr. Yishai Ofran, Rambam Health Care Campus

Phase II Prospective Study to Assess Rate for Prolonged Remission With Intensive Chemotherapy in Rapid Respondents AML Patients Younger Than 61 as Demonstrated by Day 5 Examination of the First Treatment.

We previously reported results of a prospective observational study demonstrating that early response defined as reduction in bone marrow (BM) blast counts to less than 5% of BM cells by the fifth day of induction therapy is a strong predictor of remission and overall survival (Ofran Y, et al. AJH, 2015). The long term survival benefit of early response was confirmed later on after a median follow-up for surviving patients of 53 months (range 17.5-84.5).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Patients diagnosed with AML, younger than 61 year of age assigned for intensive chemotherapy, and diagnosed with standard or intermediate risk AML, will undergo BM examination on the fifth day of induction. Patients in whom BM blast count at the fifth day of induction will be lower than 5% will proceed therapy with consolidations or autologous SCT with-holding the option for allo-SCT. MRD monitoring will apply to those with reliable molecular marker.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 61 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • AML diagnosis,
  • treated with 3+7 Induction chemotherapy
  • Intermediate/standard risk AML

Exclusion Criteria:

  • Diagnosed of APL
  • high risk molecular/cytogenetic score

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: No allogeneic SCT
For standard or intermediate risk AML patients who achieved good rapid response, allogenic SCT will be excluded from treatment plan
Procedure: Prescribing conventional chemotherapy while with holding allo-SCT
Prescribing conventional chemotherapy (chemotherapy consolidations or autologous SCT) while with holding allo-SCT
Other Names:
  • No Allogeneic for rapid responders
Active Comparator: Standard post induction therapy
For slow responding AML patients, post induction therapy will be provided according to treating physician discretion
Procedure: Prescribing conventional chemotherapy while with holding allo-SCT
Prescribing conventional chemotherapy (chemotherapy consolidations or autologous SCT) while with holding allo-SCT
Other Names:
  • No Allogeneic for rapid responders

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Event free survival
Time Frame: Two years
Two years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survivial
Time Frame: two years
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rambam Health Care Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 15, 2019

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2023

Study Registration Dates

First Submitted

April 2, 2019

First Submitted That Met QC Criteria

April 2, 2019

First Posted (Actual)

April 4, 2019

Study Record Updates

Last Update Posted (Actual)

April 8, 2019

Last Update Submitted That Met QC Criteria

April 4, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • RMB-250-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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